In this update:
- Legislative Update
- House Ways & Means Committee Introduces Two-Year Telehealth Package
- Federal Agencies
- CMS Releases Draft Implementation Guidance for IRA Drug Price Negotiation
- DOJ Announces Task Force on Health Care Monopolies and Collusion
- HHS OIG Approves Multi-Fund Patient Assistance Program Arrangement
- Medicare Trustees Project Additional Five Years of Solvency
- CMMI Introduces Increasing Organ Transplant Access Model
- HHS Publishes Final Rule on Adult Protective Services
- Other Updates
- PCORI Opens Funding Portal
- Joint Commission Announces Rural Health Clinic Accreditation
- New York State Updates
- DOH Releases Ninth Monthly Edition of the State’s Public Health Emergency Unwind Dashboard
- DOH Issues Proposed Regulations on Adult Home Admission and Reporting Requirements
Legislative Update
House Ways & Means Committee Introduces Two-Year Telehealth Package
On May 8th, the House Ways and Means Committee unanimously voted to approve the Preserving Telehealth, Hospital, and Ambulance Access Act, a legislative package that would enact a number of important policy changes for the Medicare program and federally-supported health providers. Within specific areas, the proposed legislation:
- Medicare Telehealth:
- Continues the extension of pandemic-era Medicare telehealth flexibilities through 2026;
- Delays the requirement for a periodic in-person visit through 2026, with guardrails to address fraud, principally with durable medical equipment and clinical diagnostic tests;
- Lifts originating and geographic site restrictions;
- Expands the set of providers able to furnish services;
- Allows federally qualified health centers (FQHCs) and rural health clinics (RHCs) to furnish services by telehealth;
- Extends the ability to bill for audio-only telehealth; and
- Expands hospice care recertification of eligibility via telehealth.
- Hospital at Home: Extends the CMS Hospital at Home waiver program through 2029.
- Rural Hospital Stabilization: Expands emergency services in Critical Access Hospitals and expands the designation for Rural Emergency Hospitals.
- Nursing Homes: Allows more nursing homes to continue training programs for nurses.
- Workforce: Includes the Rural Physician Workforce Preservation Act which addresses a loophole in federal residency programs that minimized placement in rural settings.
Despite the package passing out of Committee unanimously, several Representatives raised concerns about waste, fraud, and abuse. The House Energy and Commerce Committee is also poised to pass a telehealth package next week. The offsets for the bill include pharmacy benefit manager reforms from ongoing work in the Senate Finance Committee.
A fact sheet on the legislation is available here.
Federal Agencies
CMS Releases Draft Implementation Guidance for IRA Drug Price Negotiation
On May 3rd, the Centers for Medicare and Medicaid Services (CMS) issued draft guidance for public comment on the implementation of the Medicare Drug Price Negotiation Program (Negotiation Program) under the Inflation Reduction Act (IRA). The negotiations for the first set of 10 prescription drugs are currently underway, and CMS will announce an additional 15 potential drugs for a second round of negotiations by February 1, 2025. The draft guidance describes the parameters for the second round of negotiations, incorporating lessons learned. In addition, the guidance includes new policies for drug manufacturers to ensure access to the negotiated maximum fair prices (MFPs). Manufacturers may prospectively or retrospectively offer the MFP to the dispensing entity. CMS also added a Medicare Transaction Facilitator (MTF), a new vendor to manage data collection across dispensing entities and manufacturers to ensure compliance with the MFP. The guidance is open for comment for 60 days.
The fact sheet is available here, the memo is available here, and the press release is available here.
DOJ Announces Task Force on Health Care Monopolies and Collusion
On May 9th, the Department of Justice (DOJ) announced the formation of a new Task Force on Health Care Monopolies and Collusion (HCMC). The HCMC will be a group of prosecutors, health care experts, and other personnel from across the DOJ’s Antitrust Division that focuses on guiding DOJ’s enforcement strategy and policy approach in health care. Its functions may include policy advocacy, facilitating investigations, and pursuing civil and criminal enforcement actions related to health care markets. The HCMC’s director will be Katrina Rouse, a DOJ antitrust prosecutor since 2011.
DOJ issued a press release on the HCMC which is available here.
HHS OIG Approves Multi-Fund Patient Assistance Program Arrangement
On April 11th, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) issued a favorable advisory opinion regarding a patient assistance program (PAP) which offers financial assistance for out-of-pocket costs to patients with any of 12 specific rare diseases. The not-for-profit organization that requested the opinion operates a separate fund for each disease, each of which is funded by a pharmaceutical manufacturer. HHS has historically scrutinized this type of PAP arrangement for “significant fraud and abuse risks” and required them to maintain safeguards, such as maintaining broad eligibility for patients rather than limiting assistance to specific drugs or stages of a disease and operating independently from donors.
In this case, the OIG concluded that this arrangement does not implicate the Beneficiary Inducements CMP but does implicate the Anti-Kickback Statute. However, OIG also accepted that the PAP had established sufficient safeguards to prevent the risk of abuse, and therefore will not pursue enforcement against it.
Notably, OIG specified that this authorization is valid only through January 1, 2027. This date was established because OIG expects that circumstances may change due to the new statutory provision in the IRA that limits the Medicare Part D out-of-pocket maximum to $2,000 starting in 2025. It would therefore re-evaluate the program at that point.
The opinion is available here.
Medicare Trustees Project Additional Five Years of Solvency
On May 6th, HHS, the Department of the Treasury, the Department of Labor, and the Social Security Administration released the annual Social Security and Medicare Trustees Reports. Notably, the “go-broke” date for the Medicare Part A hospital insurance trust fund was pushed back by five years, to 2036. This change principally reflects higher payroll tax income than previously projected. In theory, when the fund becomes insolvent, Medicare would only be able to cover 89% of total scheduled benefits. The Report also notes that expenses are expected to drop next year due to updated Medicare Advantage payment mechanisms. For Part B, long-range projections of expenditures as a percentage of gross domestic product (GDP) are lower than previous estimates, due to lower projected spending for outpatient hospital and home health agency services. Lastly, for Part D, the expenditure share is expected to be higher than previous estimates, due to drug utilization and enrollment.
The report is available here, the fact sheet is available here, and the press release is available here.
CMMI Introduces Increasing Organ Transplant Access Model
On May 8th, the CMS Innovation Center (CMMI) announced the Increasing Organ Transplant Access (IOTA) Model, a mandatory new payment and delivery model for end-stage renal disease (ESRD) patients seeking kidney transplants. The IOTA model will test if performance-based incentives and penalties, such as including increases in the number of transplants and rates of organ acceptance and post-transplant outcomes, will increase access to successful kidney transplants, particularly from a health equity perspective. Under IOTA, additional equity-focused performance incentives would be offered with flexibilities to address health related social needs (HRSN).
An estimated 90 out of 257 transplant hospitals will be required to participate in this six-year model starting in 2025. The model is designed to complement ongoing work across CMS and Health Resources and Services Administration (HRSA).
The press release is available here.
HHS Publishes Final Rule on Adult Protective Services
On May 7th, the HHS Administration for Community Living (ACL) issued a final rule to establish the first federal regulations for Adult Protective Services (APS). With a high level of variation across states, the rule is a step towards a national APS network. To this end, the rule establishes a set of national minimum standards for state APS systems, establishes stronger protections for adults subject to or at risk of guardianship, sets a national standard for screening response time for life-endangering cases, and increases avenues to report maltreatment or neglect.
The press release is available here, and the final rule is available here.
Other Updates
PCORI Opens Funding Portal
On May 7th, the Patient-Centered Outcomes Research Institute (PCORI) opened an online portal for its latest funding opportunities. Across nine awards, researchers will investigate the clinical effectiveness of approaches to heart failure and asthma treatment, health system strategies to control hypertension, and existing medications for migraine prevention. Through this portal, applicants can submit a Letter of Intent (LOI), which PCORI is offering guidance on through a number of upcoming town halls.
The RSVP for upcoming town halls is available here.
Joint Commission Announces Rural Health Clinic Accreditation
On May 6th, the Joint Commission launched a Rural Health Clinic Accreditation program. The program received initial deeming authority from CMS, meaning that any accredited clinic is in compliance with federal regulations and eligible for Medicare reimbursement. To become accredited, a clinic must meet the Joint Commission’s standards for RHCs, which are based on CMS’s Conditions for Certification (CfCs). One of the principal goals of the program is to reduce variation across fragmented rural health systems and standalone clinics. The program will roll out this summer.
More information on the accreditation is available here.
New York State Updates
DOH Releases Ninth Monthly Edition of the State’s Public Health Emergency Unwind Dashboard
On May 8th, the New York State (NYS) Department of Health (DOH) released the ninth issue of the State’s Public Health Emergency (PHE) Unwind Dashboard, a monthly enrollment report on the renewal process for New York’s Medicaid, Child Health Plus, and Essential Plan populations. All individuals in these programs will need to renew their eligibility through May 31st.
The ninth issue includes the renewal status, demographics, and program transitions of enrollees who had a March 31st coverage end date. The report shows that 75 percent of the 626,589 individuals in this cohort have renewed their coverage across the NY State of Health marketplace and Local Departments of Social Services. The report does not include information on former enrollees who found coverage through non-public sources, such as employer-based insurance.
The ninth issue and previous issues may be accessed here. This process will continue each month until each enrollee cohort has had their eligibility redetermined.
DOH Issues Proposed Regulations on Adult Home Admission and Reporting Requirements
On May 9th, DOH issued proposed regulations for public comment that aim to clarify the pre-admission screening process and reporting process for residents with a diagnosis of serious mental illness (SMI). The proposed regulations amend sections 487.4 and 487.10 of Title 18 of the New York Codes, Rules, and Regulations (NYCRR) to require adult homes to:
- Clarify the pre-admission screening requirements for persons suspected of having SMI;
- Continue to report any resident with SMI until DOH issues a written notice to the facility that such reporting is no longer required for that resident; and
- Submit a roster of all residents to DOH on a quarterly basis.
The proposed regulations are available here. Public comment may be submitted to regsqna@health.ny.gov through July 8th.